I do not want to be a guinea pig. Why should I participate in research?
What are the benefits of joining a clinical trial?
What are the risks?
How do I know if I have been given all the information?
What if I change my mind about participants but the research is already underway?
What else should I know about medical studies?
Who participates in clinical research and how are they selected?
What if I might be pregnant?
How can I find out about clinical research?
What is the difference between a clinical trial and an observational study?
I have heard that clinical trials have different phases. What does that mean?

 

Q. I do not want to be a guinea pig. Why should I participate in research?

A. There is a great need for women in research trials. Women should participate in research because there are so few answers to some of the biggest questions in women’s health. Before 1993, studies that tested new drugs had special eligibility criteria that prohibited women from participating. Those criteria have been dropped and all women are now eligible to participate in drug studies. We do not know why heart disease kills more women over 50 years old than men of the same age. We have huge gaps in knowledge about breast cancer. We do not know much about the menstrual cycle. We do not understand why eating disorders are so prevalent in young women and nearly impossible to cure in some of them. Almost nothing is known about these topics because, until recently, most research was done using men as subjects. This is now beginning to change, and a woman can help researchers find out more, if not for herself, for her mother, her best friend and especially for her daughters.

For more information:
Research Volunteers: Medical Heroes
Research Studies for Women

 

Q. What are the benefits of joining a clinical trial?

A. Some other reasons why you might want to participate in research (or clinical trial) are listed below. However, the kind of benefits you receive depend not only on the specific study in which you participate, but can also depend on which part of the study you are randomized into, if you participate in a clinical trial. You might want to participate:

• to receive free screenings and exams,
• to learn more about health topics,
• to meet other volunteers,
• to potentially gain access to new drugs and interventions before they are widely available,
• to receive close monitoring of your health care and any side effects,
• to have a more active role in your own health care, and
• to help answer questions that can improve the health of future generations

For more information:
Taking Part in Research: Benefits and Risks

Q. What are the risks?

A. You should also consider that there may be potential risks when participating in research, especially if you are randomized to the treatment group of a clinical trial. Potential risks include:

• if you are receiving a new drug or procedure that is being tested, it may have side effects or risks unknown to the doctors, side effects and results may be worse than from interventions that are currently used, even if a new approach has benefits, it may not work for you, and health insurers and managed care providers do not always cover all the care costs in research.

For more information:
Taking Part in Research: Benefits and Risks
 

Q. How do I know if I have been given all the information?

A. If you volunteer to participate in a study, you will go through a process called informed consent. During informed consent you will learn the key facts about a study before you decide whether or not to participate. These facts include details about the study approach, the intervention actually given in the study, the possible risks and benefits and the tests you may receive. The researcher will give you written information called a consent form that goes over key facts. If you agree to take part in the study, you will be asked to sign this form. You are encouraged to take the form home and discuss it with your family, friends, or others before you make your decision. If you decide to join the research study, be sure to ask for a copy of the consent form, so you can look it over at any time.

Do not hesitate to ask questions until you have all the information you need. This is an important decision, and you should be comfortable with whatever choice you make. In fact, you should feel free to ask the research team questions at any time. Informed consent is more than a form; it is a process that continues throughout the study. For example, you may continue to have questions throughout the study, and your discussions about these questions with the health-care team are all part of the informed consent process. Informed consent continues as long as you are in the study.

For more information:
Informed Consent: What it Means to You
 

Q. What if I change my mind about participants but the research is already underway?

A. You can change your mind and leave the study whenever you want, before the study starts or at any time during the study or follow up period. Remember that participating in research is always voluntary. Even if you decide to participate in a study, you can always withdraw from the study without it affecting the relationship with your health care provider.

For more information:
Informed Consent: What it Means to You
 

Q. What else should I know about medical studies?

A. Only you can make the decision about whether or not to participate in research. Before you make your decision, you should do a little of your own research:

• Learn about your specific disease, condition, or health status.
• Find out what kind of study is being done and learn about that kind of study design.
• Find out about the research studies that might be appropriate for you.
• Get answers to all of your questions.
• Determine the potential risks and benefits of your participating in the study.
• Talk about this information and how you feel about it with your own doctor and/or nurse, family members and friends to help you determine what is right for you.

For more information:
Research Studies: Should I Take Part?
 

Q. Who participates in clinical research and how are they selected?

A. The short answer is: lots of different people participate in clinical research and they are selected in various ways. Women who participate in clinical research are volunteers who meet special criteria determined by the research study’s purposes. Every study identifies some specific characteristics that the participants should have in order to participate in the study. These characteristics are called eligibility criteria. They may include a diagnosis with a particular type of disease, the presence of certain symptoms, the absence of certain diseases or conditions, age and general health. Eligibility criteria are a key part of medical research. They help assure that the study results answer the research question. They also help doctors identify who will benefit in the future from the approach being studied if it is shown to work. For example, in cancer prevention studies, a new drug may work for people with one type of risk factor but not for another. Eligibility criteria also help insure the safety of participants by protecting them from known risks. For example, some drugs can only be given safely if a person has normal kidneys or liver. In this situation only persons with normal kidney or liver function are allowed to participate in the study.

For more information:
Being a Partner in Research: Ways to Take Part
Taking Part as a Healthy Volunteer
 

Q. What if I might be pregnant?

A. Between 1977 and 1993, the Food and Drug Administration prohibited the inclusion of women of childbearing age in the early phases of research studies that tested new drugs, unless the woman had a life-threatening disease. The FDA was concerned about the possible effects of experimental drugs on fetuses. However, many women of childbearing age are unlikely to get pregnant. For instance, women using oral, injectable, or mechanical contraception, women whose partners have had vasectomies, women who are not sexually active, and lesbians, are not likely to get pregnant. In addition, there are important scientific benefits to including women in early phases of drug research. If sex differences in the way a drug works are identified in early phases of the research, then subsequent studies can be designed more suitably so that researchers can figure out how the drug should be used to benefit women.

Secondly, it is unethical to prevent women from making their own choices about their bodies and their pregnancies. Recent laws and court decisions suggest that women should have the right to make their own risk-benefit choices about their pregnancies in employment situations, for example, and are entitled to know all the potential risks.

Third, it is possible to reduce the risk of fetal exposure through study design. By either administering the drug during or immediately following a woman’s menstrual period or after a pregnancy test, or counseling women in trials about the need to use reliable forms of contraception, the potential risk to fetuses can be avoided. Finally, it is better to know if a drug affects fetuses or affects pregnant women differently by testing the drug in a small number of pregnant women than for drugs to be used by many women during pregnancy without reliable information on their maternal and fetal effects.

For more information:
Someone is Watching Over You
 

Q. How can I find out about clinical research?

A. You can find out about research studies in several ways. Sometimes researchers place advertisements and announcements in newspapers or on the radio. Other times, your own health care provider may be conducting research herself, or may know of available research studies for which you can volunteer. Or, a researcher may give a talk at a church or women’s group asking for participants. Sometimes you can get on a mailing list at a National Centers of Excellence in Women’s Health and be notified of available studies. If you think you are interested in participating in a study you have heard about, you can call the research study office. The research staff will ask you some questions to see if you meet the eligibility criteria for that particular study. You may also have to come in for tests or exams to make sure you have the condition that is being studied, or the level of health that is required for you to participate safely. If you are eligible or asked to come in for tests or exams, you will be told more about the study so you can decide whether or not you want to participate, and be asked to sign a consent form before you participate.

For more information:
How to Find a Clinical Research Trial
Research Match and You
 

Q. What is the difference between a clinical trial and an observational study?

A. In a clinical trial, researchers are testing a new treatment, exercise, vitamins, drugs, or other forms of therapy, and comparing it to standard treatment, (the usual care recommended by doctors in that particular situation). Clinical trials are studies that evaluate the effectiveness of new interventions. There are at least two groups of people in the study, one group receiving the new therapy and one group receiving standard therapy. Sometimes the group receiving standard therapy gets what is called a placebo, a dummy pill, or treatment, that looks identical, so that no one can tell which group they are in. When neither the researchers nor the participants know which group is which, it is called a double masked or double blind study.

An observational study means the investigators are doing just that, observing. They are not giving participants any treatment, but only checking their health and perhaps monitoring special items, like a woman’s cholesterol level or blood pressure, for example.

To illustrate the difference between these two kinds of studies, suppose researchers at a mammography center are conducting a study. Staff at the center might ask a woman whose mother had breast cancer to join a study for healthy women who have a history of breast cancer in their family. Now let us say researchers split these women into two groups. One group took extra vitamin E, while the other took a dummy pill. They agreed to come back every nine months to have another mammogram. After three years, the investigators would see if one group had fewer breast cysts or suspicious lumps. This would be a clinical trial.

It is important to note that in a clinical trial, both groups, those taking the standard therapy and those taking the new therapy, are necessary to understand if and how the new therapy works. Without the group taking the placebo, researchers would not know if the new therapy works better than, worse than, or the same as standard therapy.

In an observational study, researchers might ask women to enroll in a study about breast cancer prevention. They might ask women to come into a clinic for mammography screening and to answer questions about their health and health behaviors. The researchers could then look at the questionnaires of any women who developed breast lumps to see if there might be any common patterns in the health indicators or health behaviors that are different in women who did not develop breast lumps. Information learned from this kind of study would not necessarily be conclusive, but researchers would use this information to propose a clinical trial to find a definite answer to the question. The observational study is, in a sense, a preliminary study; however, it is vital. Without these preliminary findings, researchers would not know what to test in the more conclusive clinical trials.

For more information:
Clinical Research: Studies with People

 

Q. I have heard that clinical trials have different phases. What does that mean?

A. Most clinical research that involves the testing of a new drug has an orderly series of steps. This allows researchers to ask and answer questions in a way that expands our information about the drug and its effects on people. Based on what is learned in laboratory experiments or previous trials, researchers formulate hypotheses or questions that need to be answered. Then they carefully design a clinical research study to test the hypothesis and answer the research question. It is customary to separate different kinds of trials into phases that follow one another in an orderly sequence. For instance, cancer clinical research generally falls into one of three phases.

• Phase I Trials: These first studies in people evaluate how a new drug should be administered (orally, intravenously, by injection), how often, and in what dosage. A Phase I trial usually enrolls only a small number of participants.
• Phase II Trials: A phase II trial provides preliminary information about how well the new drug works and generates more information about safety and benefit. Each Phase II study usually focuses on a particular type of cancer, for example.
• Phase III Trials: These trials compare a promising new drug, combination of drugs, or procedure with current, standard therapy. Phase III trials typically involve large numbers of people in doctors’ offices, clinics, and cancer centers nationwide. If you participate in a Phase III treatment trial, you are likely to be randomized (assigned by chance) to a group receiving either the new intervention or the standard intervention.

Trials designed in this way are also called randomized controlled trials. If you are assigned the standard intervention, you receive what experts view as the best treatment available in the realm of routine medical practice. If you are assigned the new intervention, you receive a treatment that some experts think may have significant advantages over the standard. The reason that the clinical trial has been started is that the superiority of one treatment over the other has not yet been firmly established.

 

For more information:
What is a Clinical Trial?

Contributions to this FAQ on Clinical Trials: Wake Forest University Baptist Medical Center, a National Center of Excellence in Women’s Health sponsored by the Office on Women’s Health in the Department of Health and Human Services

For more information:

Go to the Women’s Health health topic.